Orphan drug status for Mapreg

Biotech company Mapreg announced on March 18 that it has been granted orphan drug status by the EU commission.

Biotech company Mapreg announced on March 18 that it has been granted orphan drug status by the EU commission. Its lead compound MAP4343, a medication for treating spinal cord injury, has now been entered in the European Community register of orphan drugs.

A drug becomes known as 'orphan' if it is designed to treat a rare disease, illnesses that affect only five out 10,000 people in the EU. Etienne-Emile Baulieu, president of Mapreg, said: "The granting of orphan drug status in the European Union is an important step for Mapreg and for the future benefit of patients having suffered a spinal chord injury."

Orphan drug status qualifies Mapreg for scientific assistance for developing MAP4343 from the European Medicines Agency (EMEA) and exemption from regulatory approval fees. Over 20,000 spinal chord injury cases are reported every year in the West and operative therapeutic remedies and care for patients can cost between Ä1m and 2m.

Baulieu said: "The results on animal models are without parallel and we want to move forward to initiate the first clinical trails." Phase I clinical trails of MAP4343 could now begin at the end of 2008.